Who is the manufacturer of SimpleSENSE?

Nanowear, Inc. filed the 510(k) submission for SimpleSENSE (K201669).

What is the FDA product code for SimpleSENSE?

DXH. It is classified under 21 CFR 870.2920 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for SimpleSENSE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SimpleSENSE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SimpleSENSE

K201669 · Nanowear, Inc. · DXH · Nov 6, 2020 · Cardiovascular

Device Facts

Record ID	K201669
Device Name	SimpleSENSE
Applicant	Nanowear, Inc.
Product Code	DXH · Cardiovascular
Decision Date	Nov 6, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2920
Device Class	Class 2

Indications for Use

The SimpleSENSE System is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The device is intended for use when the clinician decides to evaluate the physiologic signals as an aid to diagnosis and treatment. The SimpleSENSE System is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker.

Device Story

SimpleSENSE is a wearable textile garment with integrated nanosensor electrodes and a MEMS microphone; captures 2-lead ECG, respiration rate (via thoracic impedance), heart sounds, and activity/posture. System includes a Signal Acquisition Unit (SAU) for data storage/transmission and a mobile application for iPhone (iOS 13.4) to initiate recordings and forward reports. Used at home or healthcare facilities by patients at rest; operated under clinician direction. Data is wirelessly transmitted to a smartphone and stored on a removable microSD card. Clinicians review the recorded data to aid in diagnosis and treatment of cardiac rhythm disturbances. Device does not provide real-time monitoring or alarms.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included verification of multiparametric data capture, Bluetooth/iPhone connectivity, data encryption, battery safety, SAU durability, microSD card performance, biocompatibility of the garment, sensor performance (ECG, thoracic impedance, MEMS microphone), garment mechanical/electrical performance, and shelf life.

Technological Characteristics

Wearable textile garment with integrated nanosensor electrodes and MEMS microphone. ECG: Bipolar lead instrumentation amplifier, Sigma-Delta ADC. Respiration: 4-point probe thoracic impedance. Power: Internal Li-Ion rechargeable battery. Connectivity: Bluetooth wireless to iPhone. Storage: Removable microSD card. Software: Mobile application for recording/transmission.

Indications for Use

Indicated for adult patients at rest, under direction of a licensed medical professional, for recording/storing ECG, respiration rate (thoracic impedance), heart sounds, and activity/posture as an aid to diagnosis and treatment. Contraindicated for high-risk/critical care patients, patients with pacemakers, and active real-time monitoring.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

SimplECG (K161431)

Reference Devices

Patient Monitor, models elite V5, elite V6 and elite V8 (K160981)
Eko Electronic Stethoscope System (K151319)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line. November 6, 2020 Nanowear Inc. % Melissa Walker President & CTO Graematter, Inc. 1324 Clarkson Clayton Ctr, #332 St Louis, Missouri 63011 Re: K201669 Trade/Device Name: SimpleSENSE Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH, DSB, BZQ, DPS, DQD Dated: October 4, 2020 Received: October 6, 2020 Dear Melissa Walker: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K201669 Device Name Simple SENSE #### Indications for Use (Describe) The SimpleSENSE System is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The device is intended for use when the clinician decides to evaluate the physiologic signals as an aid to diagnosis and treatment. The SimpleSENSE System is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K201669 510(k) Summary Submitter's information Nanowear, Inc. 53 Boerum Pl, Suite 3F Brooklyn, NY 11201 United States 718-637-4815 Contact: Venk Varadan 53 Boerum Pl, Suite 3F Brooklyn, NY 11201 United States Phone: 718-637-4815 Date: June 15 2020 Classification The classification for the new device is shown in the table below. | 21 CFR Reference | Product Code | Class | Trade Name | Classification Name | |---------------------|-----------------|-------|-------------|--------------------------------------------------------------| | §870.2920 | DXH | 2 | | Transmitters and Receivers, Electrocardiograph, Telephone | | §870.2770 | DSB | 2 | SimpleSENSE | Plethysmograph, Impedance | | §868.2375 | BZQ | 2 | SimpleSENSE | Monitor, Breathing Frequency | | §870.2340 | DPS | 2 | SimpleSENSE | Electrocardiograph | | §870.1875 | DQD | 2 | SimpleSENSE | Stethoscope, Electronic | Predicate The predicate device is: devices · K161431 SimplECG cleared on 11/30/2016 from Nanowear, Inc. The following devices are considered as reference devices: • K160981 Patient Monitor, models elite V5, elite V6 and elite V8 cleared on 12/22/2016 from Edan Instruments, Inc. • K151319 Eko Electronic Stethoscope System cleared on 5/18/2015 from Eko Devices, Inc. The SimpleSENSE System is intended for use at home, or at a healthcare facility, under Indications for use the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The device is intended for use when the clinician decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSENSE System is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker. {4}------------------------------------------------ Device The Nanowear SimpleSENSE device is the next generation diagnostic description monitoring technology that captures electrocardiographic (ECG) signals, respiration rate though thoracic impedance, heart sounds, activity including posture with sensors embedded on a wearable textile garment. The signals are stored and wirelessly transmitted to a smartphone, and forwarded to a medical professional for review. > The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG, respiration rate, heart sounds and activity data from patients. > The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG data from patients. The device consists of three (3) components: - The SimpleSENSE Garment: an integrated network of nanosensor electrodes for measuring ECG and respiratory rate from thoracic impedance, and incorporating a MEMS microphone for measuring heart sounds. - The SimpleSENSE Signal Acquisition Unit (SAU): data acquisition, storage, and transmission to an iPhone 7 using iOS 13.4. Incorporates an accelerometer to measure activity. - The SimpleSENSE Mobile Application: mobile application for to start/stop a recording and to forward the test report to the medical professional. {5}------------------------------------------------ | Characteristics | The table below provides a comparison of the New Device with the predicate and reference devices. | | | | | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Nanowear Inc. SimpleSENSE - New Device Current Submission | Nanowear Inc. SimplECG K161431 | Edan Instruments, Patient Monitor, models elite V5, elite V6 and elite V8 K160981 | Eko Devices Inc. Eko Electronic Stethoscope System K151319 | Comparison | | Indications for Use Statement | The SimpleSENSE system is intended for use at home, or healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The device is intended for use when the clinician decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSENSE System is intended to be used by patients at rest and not performing any activities or movements. ECG | The SimplECG is intended to aid in the diagnostic evaluation of patients, 21 years of age and above, on the order of a physician, who experience transient symptoms which may suggest the need for monitoring to manually assess their cardiac rhythm disturbance. ECG data is recorded, stored, transferred and displayed wirelessly for review by a physician who is skilled in rhythm interpretation. | The monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) | The Eko Electronic Stethoscope System is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. Eko is intended for use on pediatric and adult patients. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing. It can used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical | The SimpleSENSE offers the same ECG measures as the SimplECG; heart sounds as in the Eko device, and a subset of the measures included in the Edan Patient Monitor device. The absence of the measures does not affect the substantial equivalence of the New Device. | | Characteristic | Nanowear Inc. SimpleSENSE - New Device Current Submission | Nanowear Inc. SimplECG K161431 | Edan Instruments, Patient Monitor, models elite V5, elite V6 and elite V8 K160981 | Eko Devices Inc. Eko Electronic Stethoscope System K151319 | Comparison | | | recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring(real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker. | | and impedance cardiography (ICG). BIS is intended for use on adult and pediatric patients. ICG monitoring is intended for use on adults only. The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are additionally intended for use during patient transport inside hospitals. The monitors are not intended for MRI environments. | examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems. | | | Product Code(s) | DXH, DPS, DQD, DSB, BZQ | DXH | MHX, DSI, DRT, CBQ, DXN, DSK, CBR, DQA, NHO, CBS, NHQ, NHP, CCK, DSB, CCL, BZQ, BZK, DPS, FLL, DRG, MLD | DQD | Similar | | Characteristic | Nanowear Inc. SimpleSENSE - New Device Current Submission | Nanowear Inc. SimplECG K161431 | Edan Instruments, Patient Monitor, models elite V5, elite V6 and elite V8 K160981 | Eko Devices Inc. Eko Electronic Stethoscope System K151319 | Comparison | | Acquired Data | Electrocardiogram (EKG/ECG) Respiration Rate derived from thoracic impedance Heart Sounds | Electrocardiogram (EKG/ECG) | ECG, Respiration Rate, Temperature SpO2, pulse rate non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), Bispectral Index (BIS), respiration mechanics (RM) Impedance Cardiography (ICG). | Heart Sounds | Same measures as those found in the predicate & reference devices. The New Device captures the ECG signal in the same way as the SimplECG predicate. The New Device captures some of the measures in the Edan reference and the heart sounds as in the Eko reference. The absence of some measures does not affect the substantial equivalence of the SimpleSENSE device. | | | Electrocardiogram (EKG/ECG): Textile-based Nanosensors | Electrocardiogram (EKG/ECG): Textile-based Nanosensors | Not Applicable | Not Applicable | Same sensors as in the SimplECG device are used to capture signals | | Sensor Technology | Respiration Rate: Textile- based Nanosensors measure thoracic impedance and respiration is derived from thoracic impedance | Not Applicable | Thoracic Impedance/Impedance Cardiogram (ICG), ECG: Disposable Silver or Silver/Silver Chloride electrode. Respiration Rate: derived from thoracic impedance | Not Applicable | Both the New Device and the Edan reference measure and derive respiration rate using thoracic impedance captured via a sensor. The sensors in the two devices are different, however both types of sensors are used for | | Characteristic | Nanowear Inc. SimpleSENSE - New Device Current Submission | Nanowear Inc. SimplECG K161431 | Edan Instruments, Patient Monitor, models elite V5, elite V6 and elite V8 K160981 | Eko Devices Inc. Eko Electronic Stethoscope System K151319 | Comparison | | | | | | | physiologic signal capture in other cleared devices. | | | Heart Sound: Microelectromechanical (MEMS) microphone | Not Applicable | Not Applicable | Heart Sound: Uses a standard stethoscope diaphragm. Method of transduction and digitization of sound waves is not Available | The SimpleSENSE device uses a different sensor than the Eko reference. However, the signal acquisition and location used in both the SimpleSENSE device and the Eko reference are similar. | | | Electrocardiogram (EKG/ECG): Standard Bipolar lead instrumentation amplifier and Sigma-Delta Analog to Digital Converter. | Electrocardiogram (EKG/ECG): Standard Bipolar lead instrumentation amplifier and Sigma-Delta Analog to Digital Converter | Not Applicable | Not Applicable | The signal acquisition method in the New Device for capturing ECG signal is the same as the SimplECG predicate. | | Signal acquisition method | Respiration rate: Thoracic Impedance is measured using four-point probe using low amplitude current applied to the body and impedance measured from voltage drop derived from thoracic impedance. (Respiration Rate detection range 6 - 22 | Not Applicable | Thoracic Impedance/Impedance Cardiograph: four-point probe using low amplitude current applied to the body and impedance measured from voltage drop. Respiration Rate: derived from thoracic impedance | Not Applicable | The signal acquisition method for capturing thoracic impedance is the same as the Edan reference. | | Characteristic | Nanowear Inc. SimpleSENSE - New Device Current Submission | Nanowear Inc. SimplECG K161431 | Edan Instruments, Patient Monitor, models elite V5, elite V6 and elite V8 K160981 | Eko Devices Inc. Eko Electronic Stethoscope System K151319 | Comparison | | | breaths per minute (BPM) with accuracy ± 2 BPM) | | | | | | | Heart Sound: solid state Microelectromechanical (MEMS) microphone embedded in garment and located near Apex of heart. | Not Applicable | Not Applicable | Heart Sound: sensor embedded in a standard stethoscope attachment that can amplify, digitize and transmit data. | The signal acquisition method for detecting heart sounds is similar to the Eko reference. Both devices are placed in similar locations to detect and capture heart sounds. | | Display Type | No on-device display. | No on-device display. | On Device Display of waveforms acquired and derived parameters is available. Data can be downloaded from the device through an Ethernet connection or a USB connection. | No on-device display. Display of data is available on a smartphone through a smartphone app or on the web using web services. | Data display for the New Device is the same as the SimplECG predicate and the Eko reference that rely on wireless transmission and display on a smartphone or web- based display. | | Display Requirement | User provided display hardware for a healthcare professional to view the recorded data. A general-purpose PC/Laptop/Desktop or mobile device may be used. | User provided display hardware for a healthcare professional to view the recorded data. A general- purpose PC/Laptop/Desktop may be used. | No requirement for additional user provided hardware for display | Display available through User provided smartphone or tablet. Display also available through Web browser on any Laptop/PC/Desktop. | The Edan reference includes a display (hardware) while the New Device, the SimplECG, and the Eko reference all display the data on the user's hardware and via web based display. | | Power Source | Internally powered using Li-Ion rechargeable battery | Single Use Lithium AA type batteries | Rechargeable Lithium-Ion Battery and AC Mains supported. | Internally powered using Li-Ion rechargeable battery | All of the devices are able to operate on battery power. The Edan reference has an option | | Characteristic | Nanowear Inc. SimpleSENSE - New Device Current Submission | Nanowear Inc. SimplECG K161431 | Edan Instruments, Patient Monitor, models elite V5, elite V6 and elite V8 K160981 | Eko Devices Inc. Eko Electronic Stethoscope System K151319 | Comparison | | Internal Memory/data | Removeable MicroSD card | Removeable MicroSD card | Solid state memory non- removeable. | Solid state memory non-removeable | All devices use memory devices to store the data collected. The New Device and the SimplECG predicate use removeable cards while the Edan and Eko references use non- removable memory devices. | | Communication Interface | Wireless transceiver using Bluetooth | Wireless transceiver using Bluetooth…

SimpleSENSE

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Identification

Predicate Devices

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Submission Summary (Full Text)

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